Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
Introduction
This document discusses considerations for a robust training system for those working in or in support of a preparation for aseptic processing area (PAA) or in an Aseptic Processing Area (APA).
Aseptic processing takes place in a controlled, but non sterile environment where sterilized components are brought together and aseptically assembled. There are four major components of an aseptic processing environment; product, components, facilities and equipment, and operators. Operators, including those that prepare equipment and components for and also those that work in an aseptic processing area, are the greatest potential source of contamination. The operator qualification program, which consists of initial and ongoing training, is crucial to ensure that colleagues are prepared to fulfil their roles.
Scope
This guidance applies to operators in the preparation for aseptic processing area (PAA), the aseptic processing area (APA) and support staff only.
Recommendations & Rationale for Recommendations
Target Audience
This guidance is targeted to individuals that design, review, approve and use training systems, training effectiveness assessments and training materials for qualification of aseptic operations personnel.
Rationale for Training
Highly trained and skilled operators are critical to the quality of the aseptically produced
product. Their training and understanding of the role they play will lead to successful or
detrimental effects on final product quality. EU Annex 1 states “Much depends on the skill, training, and attitudes of the personnel involved.” The Aseptic Processing Guideline recognizes that even the best designed facilities can be compromised by poor personnel practices.
Both those working in and preparing equipment and components for aseptic processing must have an understanding of basic microbiology and APA grades, the potential impact of non-sterile product on patients, and their role in ensuring that the production environment and product is maintained with the necessary integrity and quality.
FDA’s Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, calls for knowledge and/or skill based training on aseptic technique and clean-room behavior, basic microbiology, gowning techniques, personal hygiene, and job specific training. A critical aspect of training not specified by either of these documents is education on the overall process for producing aseptic products. Knowledge based training is critical so that operators have an understanding of the overall production process, the critical role they specifically play, and the special considerations that need to be given to any sterile drug administered through injection or IV. Skill based training develops specific job skills so that operators can carry out tasks to required specifications each and every time.
Implementation of Aseptic Training System
An Aseptic Training System is very similar in form to a GMP Training System.
System Component Requirements Knowledge Based Training
Curriculum list: (see appendix 1)
- Aseptic technique and clean room behavior
- Clean Room Design
- Disinfection, Sanitization, and Sterilization Practices
- Basic Microbiology
- Environmental Monitoring
- Gowning (tutorial and practical training)
- Airlock/Pass through Practices
- Overview of Manufacturing Process including job functions and their impact
The training concepts discussed above need to be understood by the operator prior to working in the aseptic area. The exceptions would include complete job specific training which may need to be observed in the aseptic area itself as well as participation in aseptic process simulations or media fills. Retraining needs to be accomplished minimally on an annual basis, when new technology, equipment, or processes are employed, as needed for refresher training, when identify as a corrective/preventative action for a deviation, or when an operator has been absent from the aseptic work environment for a specified time as covered by site policy. Opportunity for continuous learning cannot be overemphasized.
While training is a key component, the criticality of the clean room environment necessitates the routine presence of management, or designates, to routinely assess the operators’ activity in the aseptic core, looking for opportunities for continuous improvement.
Training is more effective when the trainee can do and see as opposed to simply hearing the information. For example, simulations of unidirectional airflow using smoke generators or smoke sticks can provide a clear picture the difference quick vs. slow and deliberate movements can have on unidirectional airflow. It also demonstrates how placement of objects and equipment on and around the filling line affects the airflow patterns. Another example is videotaping operator gowning practice which can enhance gowning training as it provides a tool to the operator and trainer to be able to examine the gowning process and point out areas of improvement or determine contamination sources.
Knowledge Based Training vs. Skill Based Training
Skill Based Training is the demonstration and documentation that an operator is competent (as applicable) in specific job tasks. Demonstration of competence includes demonstrating the skills needed to do aseptic manipulations, aseptic set up, and any other movements/activities that would directly relate to the fitness of equipment or environment for use in the manufacture of sterile product.
Knowledge based training provides the understanding of why it is critical that procedures and processes are carried out in the right way. This training provides information to help operators in decisions and judgments on a daily basis.
Qualification criteria are set forth in the guidance and will also be customized by the site depending on the specific knowledge and skills needed for each job. There will be a core knowledge needed for PAA and APA operators. Curriculums will differ based on
the skills needed for individual job tasks, assessing certain activities for risks to the product, and the difficulty or complexity of the task.
Qualification Process
Initial Qualification – New colleagues moving into roles in the PAA, APA or support of these areas should go through an initial program designed to give them the background and baseline knowledge and skills to work in these areas and carry out specific assigned job tasks.
During this initial qualification, care should be taken to ensure that the training is designed so that those that may not have any background will be able to comprehend and integrate the knowledge into their daily jobs. All knowledge and skills based training must be documented. (See Appendix 2)
Annual Re-qualification – Annual Re-qualification should build on the baseline established during initial qualification. The training should be engaging and challenging enough to keep operators interested and learning. The focus each year can be changed to match site and business needs. For example, some years there may be more focus on contamination issues or investigation of environmental excursions-other years the focus may be on learning more about incoming new technology. The key is to continue the educational and skill development process. All knowledge and skills based training must be documented. (see Appendix 3)
Extended Absence Re-qualification – If an APA operator has not worked in the APA nor done sterile gowning for a significant length of time, the site must assess when demonstration of competence of critical job skills or a refresher course on certain classroom topics is required.
This assessment should take into account the absence interval, the criticality of the job skills and the operator’s individual experience and expertise. This assessment and any training associated with re-qualification must be documented. (See Appendix 4)
Re-qualification due to monitoring failure – Re-qualification should be conducted when an investigation shows that operator error due to lack of understanding or competence is the source of the EM excursions. There are many reasons that an environmental excursion could occur-changes in procedures, disinfectants, new equipment for example-that would not indicate that operator training would be needed.
The structure of this training should be handled on a case by case basis as determined by the investigation. All knowledge and skills based training must be documented.
Training Effectiveness Assessments – Assessment should be made of the operators understanding of the knowledge based training and competence in any job skills. Methods for assessing training effectiveness should be approved by the Site Quality Team and Site Production Team prior to use.
Typically, written or oral assessments or classroom activities that cover key objectives are appropriate for knowledge based training while actual documented physical demonstration of job skills is appropriate for Skill Based.
Identifying Trainers – An internal site trainer, who has expertise in this area/topic, should perform the training.
These individuals should be evaluated or trained to perform training to ensure that they have the appropriate skills and knowledge to ensure training is effective. Aseptic Qualification training is very similar to Structured On-the-Job training for any other production related process.
Therefore the evaluation/training of the trainer can be similar if not the same.
Documentation of Qualification Process – The site qualification program for APA/APA Support and PAA/PAA Support personnel should be formalized in an SOP. The SOP should include details about the Initial Qualification, Annual Re-Qualification and Re-Qualification after an absence or deviation, who is responsible for carrying out the training and approximately how long the training is expected to take.
All materials used during the Qualification/Re-Qualification process; i.e. SOP, checklist, training form, equipment manual; should be defined in the SOP process.